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NCT04100408 · ClinicalTrials.gov registry record
Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis (LCH)
A clinical trial of Histiocytosis, Langerhans-Cell, sponsored by Children's Oncology Group.
- Active
- Registry status
- 647
- Enrollment target
- 1
- Study location
NCT04100408: Active study of Histiocytosis, Langerhans-Cell, sponsored by Children's Oncology Group.
NCT04100408 is a study of Histiocytosis, Langerhans-Cell that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 647 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04100408, a study of Histiocytosis, Langerhans-Cell, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- 647 participants
- Enrollment target
- 1
- Study location
Study Summary
The long-term goal is to define the mechanisms of pathogenesis underlying Langerhans cell histiocytosis (LCH). The overall objectives of the current study are to characterize the role of SMAD6 inherited genetic variation on LCH susceptibility and identify germline genomic regions associated with LCH somatic mutations. Building from preliminary data, the central hypotheses are: (1) causal genetic variants in SMAD6 underlie susceptibility to LCH, and (2) differences in LCH-related somatic activating mutations by race/ethnicity are related to Amerindian (i.e., Native American) genetic ancestry. The Central hypothesis will be tested by pursuing the specific aims.
Primary Outcome
Will re-sequence SMAD6 among LCH case-parent trios to characterize the association between SMAD6 inherited genetic effects and LCH susceptibility using targeted next-generation sequencing. We will also analyze de novo single-nucleotide variants (SNVs), copy-number variants (CNVs), and insertions/deletions(INDELs) obtained through SMAD6 sequence data generated from the biologic samples of the CCRN/PEC LCH case-parent trios.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- OTHER Biospecimen Collection
Study Locations (1)
Texas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 647 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2026-09-30 |
What the registry record for NCT04100408 still lists
NCT04100408 is an observational study that tracks outcomes without assigning an intervention. The registered 647 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Histiocytosis, Langerhans-Cell appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT04100408 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04100408 about?
NCT04100408 is a clinical study titled "Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis (LCH)". The long-term goal is to define the mechanisms of pathogenesis underlying Langerhans cell histiocytosis (LCH). The overall objectives of the current study are to characterize the role of SMAD6 inherited genetic variation on LCH susceptibility and identify germline genomic regions associated with LCH...
What is the current status of trial NCT04100408?
This trial is currently active not recruiting. The enrollment target is 647 participants. The study started on 2020-06-01. Estimated completion is 2026-09-30.
What conditions does trial NCT04100408 study?
This clinical trial studies the following conditions: Histiocytosis, Langerhans-Cell.
What interventions are being tested in trial NCT04100408?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Biospecimen Collection (OTHER).
Who is sponsoring clinical trial NCT04100408?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04100408 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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